TINA-QUANT HBALC GEN. 3
Received Oct 25, 2024 · Event occurred Oct 2, 2024
Report 1823260-2024-03089 · MDR key 20534444
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
790123
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE CUSTOMER WAS NO LONGER USING THE COBAS 4000 C311 STAND ALONE SYSTEM FOR THIS ASSAY.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HBALC GEN. 3 (HEMOGLOBIN A1C) RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULT FROM THE COBAS C311 WAS 4.9%. THE RESULT FROM A COBAS C303 AND FROM A TOSOH-G8 ANALYZER WAS 5.6%. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS 4000 C311 STAND ALONE SYSTEM SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.